Everolimus and temozolomide as first-line treatment in advanced gastrointestinal neuroendocrine carcinoma (G3) with a Ki67 of 20-55%

Dept of Oncology. Haukeland University Hospital0 sites38 target enrollmentDecember 9, 2013

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Everolimus and temozolomide as first-line treatment in advanced gastrointestinal neuroendocrine carcinoma (G3) with a Ki67 of 20-55%
Sponsor: Dept of Oncology. Haukeland University Hospital
Enrollment: 38
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

December 9, 2013

End Date

December 1, 2019

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Dept of Oncology. Haukeland University Hospital

•Histology and staging disease:
•Histologically proven neuroendocrine carcinoma with a Ki67 of 20\-55% by local pathology review.
•Primary gastrointestinal tumor or cancer of unknown primary when metastases are mainly GI.
•The patient cannot by surgery be rendered free from disease
•General conditions:
•\>18 years;
•WHO performance status 1\.
•Adequate haematological function
•Adequate renal and hepatic functions:
•Written informed consent prior to inclusion must be obtained and documented according to the local regulatory requirements

•Prior chemotherapy for advanced/metastatic disease.
•Adjuvant chemotherapy must have ended \> 6 months before inclusion.
•Pregnancy or breast\-feeding. Fertile patients must use adequate contraception.
•Other anti\-cancer systemic treatment within the last 8 weeks, including other experimental drugs.
•Chronic infectious or immunosuppressive disease including, but not limited to, HIV, HCV and HBV.
•Uncontrolled diabetes mellitus defined as HbA1c \= 8% despite adequate therapy.
•Known hypersensitivity to temozolomide or everolimus, or related compounds.
•Patients receiving chronic treatment with corticosteroids or other immunosuppressive agents.
•Other serious medical condition or illness that according to the investigator could be negatively affected by the study treatment.
•Patients with history of another primary malignancy within the last 3 years, with the exception of locally treated non\-melanoma skin cancer and carcinoma in situ of the uterine cervix.